New hope for immunotherapy side effects: which drug works best for colitis?
NCT ID NCT04407247
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This study compares two medications, infliximab and vedolizumab, to treat colitis (colon inflammation) caused by immune checkpoint inhibitor therapy in cancer patients. About 47 adults with genitourinary cancer, melanoma, or non-small cell lung cancer are participating. The goal is to see which drug works better to control this side effect and help patients recover.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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47 people
The number who actually took part.
- Started
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Jul 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients who receive any type of immune checkpoint inhibitor (ICI) therapy * Patients with peak grade \>= 2 immune-related diarrhea and/or colitis (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 within 45 days prior to initiation of study treatment (infliximab/ vedolizumab) * Patients with ability to understand and willingness to sign informed consent * Patients with genitourinary cancer or melanoma or non-small cell lung cancer * No concern for active concomitant GI infection for immune-related diarrhea and/or colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation * Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment Exclusion Criteria: * Patients younger than 18 years of age * Patients with persistent gastrointestinal infection confirmed with positive testing despite completing 5 days of antibiotics * Patients are on concurrent immunosuppressive therapies other than what will be given for colitis * Patients with preexisting activehistory of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation * Pregnant and breastfeeding women, and * Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \> 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to initiation of study treatment * Patients who develop concurrent non-GI toxicity at the time of study treatment initiation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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